Evaluating a device for monitoring intracranial hemorrhage
A Prospective, Two-Stage, Non-randomized, Multi-center Within Patient Comparison Study to Evaluate the SENSE Device's Ability to Detect Intracranial Hemorrhage
This study is testing a new device called SENSE to see if it can better detect and monitor bleeding in the brain compared to regular CT scans for patients with brain injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Sense Diagnostics, LLC Industry-sponsored |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04642443 on ClinicalTrials.gov |
What this trial studies
This study evaluates the SENSE device's ability to detect and monitor intracranial hemorrhages compared to standard head CT scans. It involves a two-stage, multi-center, non-randomized approach where patients with primary spontaneous intracranial hemorrhage or traumatic brain injury will be enrolled. The first stage focuses on developing a detection algorithm, while the second stage tests this algorithm in an independent cohort. The study aims to enroll a total of 300 subjects to validate the effectiveness of the SENSE device against CT results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who have undergone a CT scan in a mobile stroke unit, emergency department, or hospital.
Not a fit: Patients who are pregnant, have metallic implants, or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a faster and potentially more accurate method for detecting intracranial hemorrhages.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients age 22 years and older * CT obtained in the mobile stroke unit, emergency department (ED) or hospital Exclusion Criteria: * Female patients who are pregnant or lactating * SENSE device cannot be applied within 6 hours of a standard of care CT, * Metallic intracranial clip, coil, device (such as ICP monitor), or penetrating metallic shrapnel, * Metallic EEG leads in place at the time of planned enrollment, * Open skull fracture (closed skull fracture is not an exclusion), * Placement of an intraventricular catheter prior to enrollment, Hemorrhagic transformation of ischemic stroke,) as etiology of ICH, * Treatment with intravenous thrombolysis or embolectomy prior to enrollment, * Clinical uncertainty about whether intracranial hemorrhage is present on the pre-enrollment head CT, and * Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for SENSE device monitoring or study participation or may confound the outcome of the study.
Where this trial is running
Atlanta, Georgia
- Grady — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan Ratcliff, MD — Emory University
- Study coordinator: Alex Hall, BSN
- Email: alex.hall@emory.edu
- Phone: 404-778-1585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.